Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04844944
Status:
RECRUITING
Last Update Posted:
2023-06-26
First Post:
2021-03-29
Brief Title:
The Helios Heart Registry A Standardized Registry for Patients With Specific Cardiac Diseases
Sponsor:
Helios Health Institute GmbH
Organization:
Helios Health Institute GmbH
Study Overview
Official Title:
The Helios Heart Registry A Standardized Registry for Capturing Clinical and Patient-reported Outcomes in Patients With Specific Cardiac Diseases Application of the ICHOM Standard in Clinical Practice
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H²-Registry
Brief Summary:
Investigator-initiated prospective non-randomized open label non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures
Detailed Description:
Heart failure HF coronary artery disease CAD and atrial fibrillation AF are among the most relevant cardiovascular diseases contributing to overall morbidity and mortality each itself and in particular in case of their coexistence Several new therapies have been introduced in randomized controlled trials but confirmation data of treatment effects in real-world cohorts using a standardized methodology is scarce The International Consortium for Health Outcomes Measurement ICHOM defined standard variable sets for all three diseases in order to objectively monitor the course of disease
To evaluate current health care utilization and interactions between diseases and treatments in patients with HF CAD and AF as well as patient-oriented values study initiator will build a prospective observational multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations
To evaluate current health care utilization and interactions between diseases and treatments in patients with HF CAD and AF as well as patient-oriented values study initiator will build a prospective observational multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None